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OpenTrials
Completed

NCT Number: NCT00641914

Inhaled Steroid Treatment as Regular Therapy in Early Asthma

A study of the effect of the early treatment with Pulmicort of newly diagnosed asthma. Patients will receive either Pulmicort or a non-active treatment for three years. Neither patients or investigators will be aware of the treatment received. After three years of treatment all patients will receive Pulmicort for 2 further years.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

6 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female patients aged between 6 and 60 years
  • diagnosed with asthma within 2 years of starting the study
  • Ability to use a Turbuhaler

Exclusion criteria

  • Symptoms indicating asthma (e.g. wheezing) for more than two years prior to starting the study
  • A history of the use of treatments like Pulmicort for more than 30 days per year in the two years before starting the study
  • Regular daily treatment for asthma for more than two years before starting the study

Treatment and study plan

Budesonide

Drug

Other names: Pulmicort

Placebo

Drug

Primary outcomes

  1. Severe asthma related events (SARE) (part A); post-bronchodilator FEV1 % of predicted normal (part B)

    Time frame: At week 6 and12, and every 3 months thereafter

Secondary outcomes

  1. Pre-bronchodilator FEV1 % of predicted normal

    Time frame: At week 6 and12, and every 3 months thereafter

  2. HE: Asthma related events and health care utilisation, and symptom free days (SFD)

    Time frame: At week 6 and12, and every 3 months thereafter

  3. Post-bronchodilator FVC % of predicted

    Time frame: At week 6 and12, and every 3 months thereafter

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

Inhaled Steroid Treatment As Regular Therapy in Early Asthma. A Study on the Effect of Early Intervention With Long-Term Inhaled Budesonide (Pulmicort Turbuhaler ® ) in Newly Diagnosed Asthma.

Acronym: START

Important dates

Study start
1996
Primary completion
2003
Study completion
2003
First posted
Mar 24, 2008
Registry last updated
Mar 25, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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